Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women (URGE-I)

Klinikum der Universität Köln

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Urge Urinary Incontinence

Treatments: Procedure: cesa/vasa; Drug: solifenacin

Study type: Interventional

Funder types: Other

Identifiers

NCT01737411

URGE-I (Other Identifier)

11-016

Details and patient eligibility

About

The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment.

Full description

Urge Urinary Incontinence affects 30% of postmenopausal women. The etiology is unknown therefore treatment is symptomatic. For that purpose the nerval stimulation of the bladder muscle is interfered by several drugs, e.g. solifenacin.

We observed that the surgical repair of critical pelvic structures, i.e. the uteri-sacral ligaments (USL) can restore continence in a considerable number of patients.

In this study the surgical treatment is compared with the solifenacin treatment. According to outcome after three months patients who are still incontinent are referred to the opposite treatment group.

Outcome will be differentiated in cure (primary aim) and improvement of symptoms (secondary aim).

Enrollment: 120 estimated patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• urge urinary incontinence

Exclusion criteria

• stress urinary incontinence
• cancer disease of the females genital tract
• pregnancy
• neurologic/psychological reasons for incontinence
• body weight >100kg
• previous urogynecological surgery (TVT)
• syndrome of dry overactive bladder (>20 micturitions within 24 hours)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

solifenacin

Active Comparator group

Description:

10 mg solifenacin per day for three months

Treatment:

Drug: solifenacin

cesa/vasa

Experimental group

Description:

repair of USL

Treatment:

Procedure: cesa/vasa